FDA Clears Pear’s Digital Therapeutic for Chronic Insomnia

The FDA granted 510(k) clearance to Pear Therapeutics for Somryst, a prescription-only digital therapeutic device for chronic insomnia.

The software app is for chronic insomnia in adults 22 and older that is used on a mobile device such as a smartphone or tablet. The treatment provides cognitive behavioral therapy for the sleep disorder and sleep restriction driven by algorithms.

Data from two randomized clinical trials showed the treatment provided clinically meaning improvements in insomnia severity, time to fall asleep and time spent awake at night at the end of treatment.